21 sep
|
ClinChoice
|
México
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.
ClinChoice is a general full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Responsibilities
· Accountable for aligned markets for required regulatory in-scope ancillaries and samples
· Understand aligned markets regulatory ancillary requirements
· Manage aligned markets ancillary and samples requests are completed per agreed timelines in support of planned regulatory submissions
· Manage in a matrix environment with effective communication across multiple functions
· Escalate to Client and Contractor point of contact when timelines may not be reached.
· Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all users.
Minimum requirements
- 3+ years Regulatory experience
- Demonstrated ability to support international product approval
- Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
- Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
- Can demonstrate leadership and team skills.
- Advanced Microsoft Office Suite skills.
- Highly efficient communicator.
- Acts decisively and seizes accountability
- Bachelor’s degree Level (desirable or equivalent work experience.
- Familiarity with pharmaceutical organizational Structures.
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The Application Process
Once you have submitted your CV, you will
📌 Regulatory Affairs Associate Consultant- PLM (México)
🏢 ClinChoice
📍 México